Effect of neuromuscular electrical stimulation (NMES) on the treatment of patients with type 2 diabetes.

This pilot, randomized, controlled clinical trial will be carried out to gain knowledge about the effect of lower extremity neuromuscular electrical stimulation (NMES) on the health status and life quality of patients with type 2 diabetes treated with insulin. The study will compare the effects of treating adult patients with insulin only (the control group) and with insulin in conjunction with lower extremity NMES (the ES group) after 12 weeks of intervention. All patients will be directed to the study following an examination by a physician. Patients will be thoroughly informed about the purpose and course of the study. Demographic information on the patients will be compiled during standardized interviews and physical examinations, as well as from additional examinations of the patients and the documentation of their concomitant diseases. Patients will be enrolled for this clinical trial based on the results of medical examinations and additional tests, such as resting electrocardiography (ECG), echocardiography (USG), 24-hour ambulatory blood pressure monitoring (ABPM), laboratory tests (glucose, glycated haemoglobin, total lipid cholesterol and HDL fractions, LDL and triglycerides, creatinine, transaminase, electrolytes). Patients in the experimental group will be treated with insulin following the clinical recommendations for the treatment of diabetic patients published by the Polish Diabetes Association. Electrical stimulation Additionally the experimental group will receive neuro-muscular electrical stimulation of the lower extremity muscles. Electrical stimulation will be performed using a portable dual-channel stimulation system TrioStim by Mettler Electronics. Biphasic, symmetrical, rectangular pulses (0.3 ms) at a frequency of 35 pulses/sec will be delivered to the quadriceps femoris and triceps surae of both lower extremities. Electrodes (5cm x 5cm) will be attached to the proximal and distal parts of the muscle bellies. Amperage will be set individually for each patient to ensure painless muscle contraction. A 2-second muscle contraction (time on) will be followed by a 4-second break (time off). NMES will be applied for 60 minutes. First both quadriceps will be stimulated for 30 minutes and then the triceps surae muscles for another 30 minutes. Treatments will be applied 5 days a week for 12 weeks (a total of 60 therapeutic sessions). In each therapeutic session NMES will be performed on both lower limbs. During the first 20 minutes, the quadriceps muscles of the right and left lower limbs will be subjected to electrostimulation, and for the next 20 minutes the triceps of the calves of both lower limbs. In total, each therapeutic session will last 40 minutes Before the start of a series of NMES treatments, all patients will be trained by the physiotherapist how to perform NMES. Patients will also be informed about the potential side effects of electrostimilation (eg skin irritation, painfulness during the procedure, etc.). Patients will then perform their own NMES at home. Each electrostimulation treatment will be recorded by the patient in a special diary. Every day an SMS will be sent to the patient, reminding him that he needs to have NMES. Every two days the therapist will contact the patient by phone asking if the treatments were done and whether they were made to the full extent. In the case of side effects, the patient will contact the therapist or doctor, if necessary a therapist or doctor will come to the patient's home to check for any symptoms. The duration of the battery supply to the ES is about 6-7 days, so once a week the therapist will come to the patient to replace the battery. The battery consumption will also be a confirmation of the NMES patients' performance.